Irrigation Set 1/2Y (32.F0139.00) - Omnia - Delynov

What is the Omnia 1/2Y irrigation set?

The 1/2Y irrigation set (reference 32.F0139.00) manufactured by Omnia is a single-use medical device intended for the management of cooling fluids in a sterile environment. This set consists of specific tubing allowing the connection of an irrigation liquid source, such as a saline bag, to the handpieces or micromotors used in surgery. Its Y-shaped structure allows for an adapted distribution of the flow to the instruments. As a critical component of operating room asepsis, this Omnia device guarantees that the liquid delivered to the surgical site remains free of any contamination, thus meeting the strict requirements of dental and implant care environments.

What are the clinical indications?

This surgical irrigation set is indicated for all oral surgery procedures requiring active cooling of hard tissues and rotating instruments. It is particularly used during implant placement, complex tooth extractions, alveoloplasties, or invasive periodontal surgeries. The use of a universal irrigation line is essential to prevent thermal necrosis of the alveolar bone, a key factor for successful osseointegration. The device maintains a low temperature at the cutting zone while ensuring continuous cleaning of the operative field by evacuating bone debris and blood, thus offering better visibility to the surgeon.

What are the technical characteristics of set 32.F0139.00?

The Omnia 1/2Y irrigation set, bearing technical reference 32.F0139.00, is designed to adapt to the standards of micro-motor equipment found in dental practices. Although specific dimensions are not detailed in the provided technical documentation, this type of 1/2Y set is generally configured to offer compatibility with specific systems such as Piezon. The device is delivered in sterile packaging to guarantee maximum safety from the moment it is opened. It integrates perfectly into a sterile surgery protocol, allowing easy handling of the tubing without compromising the surgical field. Its design aims to ensure a steady and uninterrupted flow of the irrigation solution.

What are the contraindications for use?

According to data from the manufacturer Omnia S.p.A., there are no specific medical contraindications listed for this device, other than those related to the surgical practice itself. However, the use of this irrigation set is strictly reserved for qualified healthcare professionals trained in oral surgery techniques. It is imperative not to use the product if the sterile packaging is damaged, as the integrity of the sterile barrier is essential to prevent post-operative infections. The product is for single use; any attempt at resterilization or reuse is prohibited to avoid risks of cross-contamination and degradation of the tubing materials.

What are the precautions for use for this device?

The Omnia irrigation set must be handled with care to avoid any kinking or obstruction of the tubing which could interrupt the flow of the saline solution. Before any intervention, the practitioner must carefully read the instructions for use provided by Omnia S.R.L. It is advisable to check the compatibility of the 1/2Y connector with the micromotor or insert used (Piezon type or other). As it is a non-resorbable device external to the human body, precautions focus on maintaining the sterile chain from the connection to the fluid bag to the handpiece. After use, the set must be disposed of in accordance with protocols for the management of infectious clinical waste (DASRI).

Who is the manufacturer and what standards are respected?

The 1/2Y irrigation set is manufactured by Omnia S.p.A. (or Omnia S.R.L.), a company located in Fidenza, Italy, recognized for its expertise in sterile dental surgery devices. This product is classified as a Class I medical device, in accordance with current European regulations. It bears the CE1459 marking, certifying its compliance with the safety and performance requirements of the Medical Device Directive or Regulation (MDR). Compliance with these standards guarantees dental surgeons and implantologists reliable equipment, tested and validated for demanding clinical use in hospital or private practice settings.

State of the art

Surgical medical consumables play a decisive role in operative safety.